Allogeneic haemopoietic stem cell transplant Other
Conditions
Interventions
We plan to recruit 60 evaluable participants who are due to undergo a HSCT at Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s Hospital, and will follow them up over 12 months follow
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent form 2. Aged 16 years old or above 3. Due to undergo an allogeneic-HSCT at Cambridge University Hospitals NHS Foundation Trust Addenbrooke’s Hospital 4. Confirmed determination of donor AND recipient CMV status by serology 5. Due to take Letermovir prophylaxis following the allogeneic-HSCT 6. Willing and able to comply with scheduled visits, treatment plans, sample collections and other study procedures for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Patient is CMV seronegative 2. Patient is in receipt of virus-specific T cell therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of stable CMV-specific T-cell immune reconstitution in the context of Letermovir prophylaxis, defined as two reactive QF-CMV responses, measured using QuantiFERON-CMV ELISA assay at week 6 and 8 post allogenic-HSCT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CMV viraemia, disease, mutation and mortality measured using data collected from SoC results recorded in the medical notes at 52 weeks 2. Cost savings if letermovir is stopped after 8 weeks rather than 100 days in those with stable CMV-specific T-cell immune reconstitution, measured using data collected from SoC results recorded in the medical notes at 6, 8, 12 and 52 weeks follow-ups | — |
Countries
England, United Kingdom
Contacts
Public ContactAlexandra Azevedo
Outcome results
None listed